FDA Barcode Specifications
- Codabar and ISBT 128 are the two FDA permissible barcode types.barcode image by bofotolux from Fotolia.com
On Feb. 26, 2004, the U.S. Food and Drug Administration published stipulations for barcodes on certain medications and biological products. Among other things, the FDA says that all medication labels carry a scannable barcode encoded with specified information for the identification of drugs. FDA rules require that all blood and blood component containers bear labels containing similar information on a scannable barcode. Specifications for barcodes stipulate required information and parameters. - As per FDA specifications, the word barcode must be taken literally in regards to medication and biological product labels. Hospitals, pharmacies, and other drug or blood distributors are forbidden from using automatic identification technology barcode substitutions, such as a frequency identification chip or a two-dimensional symbology. The FDA further specifies that barcodes must be linear in nature and must be readable by scanners and other similar machines. If wrapping is placed over the barcode, the wrapping must be either read-through or contain a barcode for scanning.
- FDA requirements specify that medication barcodes must at the very least the National Drug Code, or NDC, 10-character identification number for the medication, embedded in which is the name of the medication, the dosage, and the drug company that produces the medication. NDC drug codes contain asterisks, which cannot be embedded on barcodes. As per FDA specifications, nothing is to be used in place of an asterisk. Additional information that may be included in medication barcodes are the expiration date and lot number of the medication.
- A minimum of four pieces of information is required for inclusion on blood and blood-product labels, per FDA specifications. That information includes: a unique identifier for the facility from which the blood or blood product came; a lot number identifying the donor of the blood; a product code; and the blood type as described by both the ABO and Rh blood-identification systems. Blood products that must be coded include all transfusion products, such as splits units, pooled units, pedi-packs and syringes.
Basic Specifications
Medication Information Specifications
Blood Information Specifications
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